USA Regulations Archives

Hello April, spring related motivational quote, isolated on white background, vector illustration. Handwritten letters, Japanese sakura branch, little cute flowers falling. Used by Patient Guard Medical Device and IVD Regulatory and Quality Assurance consultancy agency for their April news letter.

April 2024 – News Letter

EU Regulations, Guides and Advice, Patient Guard News, Standards, UK Regulations, USA Regulations / David Small

As we step into the spring of 2024, we are delighted to present the latest edition of Patient Guard’s Newsletter, dedicated to providing you with insightful updates and invaluable resources in medical device and In Vitro Diagnostics (IVD) regulatory affairs and quality assurance consultancy.

We have been busy updating our website to change it from a generic consultancy website to an informative resource for medical device and IVD information.

April 2024 – News Letter Read More »

The risk management of medical devices following ISO 14971

ISO 14971 and the Risk Management of Medical Devices

Blog, EU Regulations, Guides and Advice, Standards, UK Regulations, USA Regulations / David Small

In the world of medical devices, ensuring both safety and compliance with industry standards is paramount. One such crucial standard is ISO 14971, a guideline that outlines the application of risk management to medical devices. In this blog post, we will delve into the significance of ISO 14971 in medical device compliance and explore how tools like Patient Guard can aid in achieving and maintaining compliance with this essential standard.

ISO 14971 and the Risk Management of Medical Devices Read More »

A certificate that says 'ISO 13485 certified' on it - This image is used by patient guard to represent ISO 13485 quality assurance and QMS services.

What is ISO 13485?

Blog, EU Regulations, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, Quality Assurance, Quality Management, Standards, UK Regulations, USA Regulations / David Small

ISO 13485 is an international standard for mapping what is required from a medical device. The system ensures that medical devices are effective and consistent throughout their life cycle, from planning and production to disposal.

Ensuring consistency is extremely important for medical devices, as patient safety could be at risk. Implementing quality management systems can also provide protection for manufacturers and their reputations, as risks can be easily identified and rectified.

Medical device regulation varies based on the classification of the medical device being manufactured. All parties are required to demonstrate compliance, from the medical device manufacturing process to the disposal of the product.

What is ISO 13485? Read More »

image of a colourful world map - used by patient guard limited on their blog about global medical device and IVD registrations.

Medical Device & IVD registration

Blog, EU Regulations, UK Regulations, USA Regulations / David Small

Medical device registration is an essential part of commercialising your medical device or IVD. First requires you to obtain registration and approval from regulatory agencies in each country where you plan to sell your device. Device registration requirements can vary significantly from country to country, which can create compliance challenges for companies pursuing multiple-market strategies.

Medical Device & IVD registration Read More »

Blood Pressure Cuff, scissors, syringe, stethoscope placed on a white background - Represents medical devices - image used by patient guard to represent subjects relating to medical device and IVD regulatory affairs and Quality Assurance.

Medical Device Start-up – is not applying a regulatory strategy early on costing more in the long run?

Blog, EU Regulations, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, UK Regulations, USA Regulations / David Small

Starting a medical device company can be a stressful time, what with design and development activities, finding funding, ensuring you don’t run out of capital etc.

One very important area that is often not considered early enough is the regulatory side. Many medical device startup companies think that the regulatory activities don’t begin until the device has been developed and they often don’t realise the cost involved in ensuring that the medical device meets the safety requirements of the medical device regulations globally

Medical Device Start-up – is not applying a regulatory strategy early on costing more in the long run? Read More »

Image shows a Doctor in green scrubs with folded arms - This image is used by Patient Guard to describe its medical device and IVD regulatory and quality assurance related content.

What is the importance of medical device registration?

Blog, Client Questions, EU Regulations, UK Regulations, USA Regulations / David Small

The main reason medical device registration is so important is safety. Ensuring that devices meet medical device regulations means that everyone involved can be confident that they are safe for their intended use. All medical devices are extremely important and can have life-saving capabilities. This means that devices must be working to their full potential.

What is the importance of medical device registration? Read More »

In vitro diagnostic regulations (IVDR), patient guard is a leading IVD consultancy

IVD Directive Essential Requirements Checklist

Blog, Client Questions, USA Regulations / David Small

The 8 Step Essential Requirement checklist for IVD Directive. The IVDR EU 2017/746 is responsible for governing the regulatory market access for in vitro diagnostic (IVDR) medical devices. It also includes the requirements for each device’s technical documentation. The information can vary based on the classification of the device, but it is always the main piece of evidence within the essential requirements.

IVD Directive Essential Requirements Checklist Read More »

USA Regulations

April 2024 – News Letter

ISO 14971 and the Risk Management of Medical Devices

What is ISO 13485?

Medical Device & IVD registration

Medical Device Start-up – is not applying a regulatory strategy early on costing more in the long run?

What is the importance of medical device registration?

IVD Directive Essential Requirements Checklist

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